Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.

Hypotension Clinical Trial

Official title:

Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736498
• Other study ID #: 308/075/076
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: February 2021
• Source: Tribhuvan University, Nepal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypotension is common during spinal anesthesia and contributes to underperfusion and ischemia. Severe episodes of intraoperative hypotension is an independent risk factor for myocardial infarction, stroke, heart failure, acute kidney injury, prolonged hospital stay and increased one year mortality rates. Empiric fluid preloading can be done to decrease the incidence of hypotension but carries risk of fluid overload especially in elderly and cardiac patients. Inferior venacava ultrasonography (IVC USG) has been used in spontaneously breathing critically ill patients for volume responsiveness but there is limited data regarding its use for volume optimization in perioperative setting. The aim of this study is to evaluate the use of inferior venacava ultrasound to guide fluid management for prevention of hypotension after spinal anesthesia.

Description:

Introduction: Hypotension is common during spinal anesthesia and contributes to underperfusion and ischemia. It occurs due to reduction in both cardiac output and systemic vascular resistance. Even short duration of intraoperative MAP less than 55 mmHg has been found to be associated with Acute kidney injury (AKI) and myocardial injury. Severe episodes of intraoperative hypotension is an independent risk factor for myocardial infarction, stroke, heart failure, acute kidney injury, prolonged hospital stay and increased 1 year mortality rates. Predictive variables for spinal anesthesia induced hypotension includes peak sensory level, chronic alcohol consumption, emergency surgery, age more than 40 years, hypertension, combined spinal/general anaesthesia(GA), spinal puncture at or above lumbar 2 lumber 3 (L2L3) interspace. Preoperative volume status is an important factor determining patient's hemodynamic status. Traditional static parameters such as central venous pressure have been criticized for invasiveness and lack of accuracy. Newer noninvasive dynamic parameters like inferior venacava diameter and Collapsibility index(CI), acoustic echocardiography, stroke volume variation and pulse pressure variation etc are being used widely for assessing volume status. Study Objective: To evaluate the use of inferior vena cava ultrasound to guide fluid management for prevention of hypotension after spinal anesthesia. Design: A randomized prospective interventional study Sample size: 92 Place: Operating theatres of Tribhuvan University Teaching Hospital (TUTH), Maharajgunj Medical Campus (MMC), Institute of Medicine (IOM). Interventions: A total of 92 patients undergoing lower limb orthopedic surgery will be enrolled in the study. They will be randomized into USG group and Control group. In the USG group, IVC ultrasound will be done and collapsibility index (CI) will be calculated. Depending upon the value of calculated CI, fluid management will be done by infusing Ringer's Lactate (RL). Thereafter spinal anesthesia will be performed. In the control group, spinal anesthesia will be performed without IVC USG assessment. In both the groups, incidence of hypotension and amount of fluid and vasopressors administered will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 20, 2020
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age =16-65 years

2. American Society of Anaesthesiology physical status (ASA PS) I and II

3. Requiring elective spinal anaesthesia for lower limb orthopaedic surgery

Exclusion Criteria:

1. Patients with pre-procedural hypotension, defined as two consecutive measurements of systolic arterial pressure (SAP) less than 90 mmHg or mean arterial pressure (MAP) less of 60 mmHg.

2. Contraindication for Spinal Anaesthesia

• Platelet counts ?100,000 per microlitre of blood
• International normalized ratio (INR) =1.5
• Bleeding disorders
• Infection at injection site

Related Conditions & MeSH terms

• Fluid Overload
• Hypotension

Intervention

Other:
• Inferior venacava Ultrasonography (IVC USG) guided fluid management
The IVC will be visualized using a paramedian long-axis view via a subcostal approach. A two-dimensional image of the IVC as it enters the right atrium will be first obtained. Variations in IVC diameter with respiration will be assessed using M-mode imaging performed 2 to 3 cm distal to the junction of right atrium and IVC. Maximum and minimum diameter will be measured from inner wall to inner wall and collapsibility index(CI) will be calculated using formula: CI = [(dIVCmax - dIVCmin)/dIVCmax] x 100% CI of ?36% will be accepted as predicted fluid responder and =36% will be regarded as predicted fluid non responders. Predicted fluid responders will receive a bolus of 500 ml of Ringer's lactate over a time period of 15 min, after which the IVC diameter variation will be reassessed. Additional 250ml of Ringer's lactate bolus will be applied until a non fluid responder pattern is observed during IVC USG. Thereafter,spinal anaesthesia will be performed.

Locations

Country	Name	City	State
Nepal	Semanta Dahal	Maharajgunj	Bagmati

Sponsors (2)

Lead Sponsor	Collaborator
Tribhuvan University, Nepal	Tribhuvan University

Country where clinical trial is conducted

Nepal, 

References & Publications (27)

Bajwa SJ, Kulshrestha A, Jindal R. Co-loading or pre-loading for prevention of hypotension after spinal anaesthesia! a therapeutic dilemma. Anesth Essays Res. 2013 May-Aug;7(2):155-9. doi: 10.4103/0259-1162.118943. Review. — View Citation

Brull R, Macfarlane A, Chan V. Spinal, epidural and caudal anesthesia. In: Miller RD, editor. Miller's anesthesia. 8th ed: Elsevier; 2015.

Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. — View Citation

Ceruti S, Anselmi L, Minotti B, Franceschini D, Aguirre J, Borgeat A, Saporito A. Prevention of arterial hypotension after spinal anaesthesia using vena cava ultrasound to guide fluid management. Br J Anaesth. 2018 Jan;120(1):101-108. doi: 10.1016/j.bja.2017.08.001. Epub 2017 Nov 23. — View Citation

Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117. Review. — View Citation

Chinachoti T, Tritrakarn T. Prospective study of hypotension and bradycardia during spinal anesthesia with bupivacaine: incidence and risk factors, part two. J Med Assoc Thai. 2007 Mar;90(3):492-501. — View Citation

Corl KA, George NR, Romanoff J, Levinson AT, Chheng DB, Merchant RC, Levy MM, Napoli AM. Inferior vena cava collapsibility detects fluid responsiveness among spontaneously breathing critically-ill patients. J Crit Care. 2017 Oct;41:130-137. doi: 10.1016/j.jcrc.2017.05.008. Epub 2017 May 12. — View Citation

Di Pietro S, Falaschi F, Bruno A, Perrone T, Musella V, Perlini S. The learning curve of sonographic inferior vena cava evaluation by novice medical students: the Pavia experience. J Ultrasound. 2018 Jun;21(2):137-144. doi: 10.1007/s40477-018-0292-7. Epub 2018 Mar 21. — View Citation

Doherty M, Buggy DJ. Intraoperative fluids: how much is too much? Br J Anaesth. 2012 Jul;109(1):69-79. doi: 10.1093/bja/aes171. Epub 2012 Jun 1. Review. — View Citation

Kalantari K, Chang JN, Ronco C, Rosner MH. Assessment of intravascular volume status and volume responsiveness in critically ill patients. Kidney Int. 2013 Jun;83(6):1017-28. doi: 10.1038/ki.2012.424. Epub 2013 Jan 9. Review. — View Citation

Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17. — View Citation

Lansdorp B, Lemson J, van Putten MJ, de Keijzer A, van der Hoeven JG, Pickkers P. Dynamic indices do not predict volume responsiveness in routine clinical practice. Br J Anaesth. 2012 Mar;108(3):395-401. doi: 10.1093/bja/aer411. Epub 2011 Dec 20. — View Citation

Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331. Review. — View Citation

Minto G, Scott MJ, Miller TE. Monitoring needs and goal-directed fluid therapy within an enhanced recovery program. Anesthesiol Clin. 2015 Mar;33(1):35-49. doi: 10.1016/j.anclin.2014.11.003. Review. — View Citation

Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756. Erratum in: Anesthesiology. 2016 Mar;124(3):741-2. — View Citation

Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672. — View Citation

Preau S, Bortolotti P, Colling D, Dewavrin F, Colas V, Voisin B, Onimus T, Drumez E, Durocher A, Redheuil A, Saulnier F. Diagnostic Accuracy of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis and Acute Circulatory Failure. Crit Care Med. 2017 Mar;45(3):e290-e297. doi: 10.1097/CCM.0000000000002090. — View Citation

Salama ER, Elkashlan M. Pre-operative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):297-302. doi: 10.1097/EJA.0000000000000956. Erratum in: Eur J Anaesthesiol. 2019 Nov;36(11):888. — View Citation

Salinas FV, Sueda LA, Liu SS. Physiology of spinal anaesthesia and practical suggestions for successful spinal anaesthesia. Best Pract Res Clin Anaesthesiol. 2003 Sep;17(3):289-303. Review. — View Citation

Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. — View Citation

Singh J, Ranjit S, Shrestha S, Sharma R, Marahatta SB. Effect of preloading on hemodynamic of the patient undergoing surgery under spinal anaesthesia. Kathmandu Univ Med J (KUMJ). 2010 Apr-Jun;8(30):216-21. — View Citation

Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765. — View Citation

Szabó M, Bozó A, Darvas K, Horváth A, Iványi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4. — View Citation

Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26. — View Citation

Wulf HF. The centennial of spinal anesthesia. Anesthesiology. 1998 Aug;89(2):500-6. — View Citation

Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002. — View Citation

Zhang Z, Xu X, Ye S, Xu L. Ultrasonographic measurement of the respiratory variation in the inferior vena cava diameter is predictive of fluid responsiveness in critically ill patients: systematic review and meta-analysis. Ultrasound Med Biol. 2014 May;40(5):845-53. doi: 10.1016/j.ultrasmedbio.2013.12.010. Epub 2014 Feb 2. Review. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of incidence of hypotension between two groups	To compare the incidence of hypotension after spinal anesthesia between two groups, USG group who have undergone volemic optimization after USG assessment and control group.	30 minutes after spinal anaesthesia
Secondary	Analyse amount of fluids administered between two groups	To compare fluid adjustment requirement between USG group and control group	30 minutes after spinal anaesthesia
Secondary	Compare vasopressors used between two groups	To compare the rate of vasopressors used between USG group and control group	30 minutes after spinal anaesthesia